NCT04860531|CompletedPhase 3DMC
The Role of Intra-articular Injection of PRP Versus Corticosteriods in Treatment of Lumbar Facet Disease
PRP
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Sponsor study identifier
interventional
30
1 country
1
Study Start
September 17, 2019
Actual (reported)Primary Completion
January 22, 2021
Actual (reported)Study Completion
January 22, 2021
Actual (reported)Low back pain is an extremely common health problem and recent studies have shown that nearly up to 52% of patients have low back pain caused by lumbar facet joint syndrome. Intra-articular injection of facet joints has gradually become one of the vital therapeutic methods for lumbar facet joint syndrome, Steroid is one of the most commonly used injected drugs; however, previous studies have indicated that it has limited ability in long-term relief of low back pain. Therefore, it seems meaningful to apply a new injectable drug and to prove its effectiveness and safety for the treatment of lumbar facet joint syndrome. Recent studies indicate that autologous platelet rich plasma(PRP) is an appropriate injectable material with great potential in treating many different musculoskeletal disorders and currently it is not yet used on a wide scale as a treatment for lumbar facet joint synovitis. In this study the investigators compare the efficacy and safety of Intra-articular injection of PRP versus conventional steriods in patients with lumbar facet joint synovitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 22, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2019
Actual (reported)January 3, 2021
Actual (reported)January 22, 2021
Actual (reported)January 22, 2021
Actual (reported)April 27, 2021
Actual (reported)The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing total number of lumbar facet joints showing tenderness on palpation on clinical examination
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of total Number of lumbar facet joints showing tenderness on palpation in each participant documented just before the intervention and at 3 month after the intervention
at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing maximum active lumber extension angle measured by goniometer
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Maximum active lumber extension measured by goniometer in each participants documented just before the intervention and at 3 month after the intervention
at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing the Visual analogue score (VAS)
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Visual analogue score documented just before the intervention and at 3 month after the intervention where score of 0 denotes absence of pain and score of 10 denotes maximum pain and decrease in the sore denotes improvement as regards low back pain reported by the participants
at 3 month follow up post intervention for each patient
The participants are randomly assigned for intra-articular injection with autologous platelet rich plasma . The treated segments are determined by clinical signs and MRI detected facet joint synovitis .
The participants are randomly assigned for intra-articular injection with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .
Floroscopy guided by C-arm Intraarticular injection in Lumbar facet Joints
Lumbar Facet Joints intra-articular injection
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordAin Shams University hospitals
Cairo, Egypt
Wu J, Du Z, Lv Y, Zhang J, Xiong W, Wang R, Liu R, Zhang G, Liu Q. A New Technique for the Treatment of Lumbar Facet Joint Syndrome Using Intra-articular Injection with Autologous Platelet Rich Plasma. Pain Physician. 2016 Nov-Dec;19(8):617-625.
Wu J, Zhou J, Liu C, Zhang J, Xiong W, Lv Y, Liu R, Wang R, Du Z, Zhang G, Liu Q. A Prospective Study Comparing Platelet-Rich Plasma and Local Anesthetic (LA)/Corticosteroid in Intra-Articular Injection for the Treatment of Lumbar Facet Joint Syndrome. Pain Pract. 2017 Sep;17(7):914-924. doi: 10.1111/papr.12544. Epub 2017 Feb 22.
Nahed Monir, Professor
Faculty of Medicine Ain Shams University
Hala Abdelhady, Professor
Faculty of Medicine Ain Shams University
Sahar Fathy, Professor
Faculty of Medicine Ain Shams University
Hossam Sakr
Faculty of Medicine Ain Shams University
30 participants (actual enrollment reported by the registry).
First Submitted
January 3, 2021
First Posted
April 27, 2021
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Roland Morris Disability questionnaire score (RMQ)
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Roland Morris Disability questionnaire score (RMQ) documented just before the intervention and at 3 month after the intervention, where score 0 denotes absence of any disability and score of 24 denotes maximum disability of the participants and decrease in the score documented denotes improvement
at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Functional questionnaire score - Oswestry Disability Index ODI
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Oswestry Disability Index score (ODI) documented just before the intervention and at 3 month after the intervention, where score of 0% denotes fully functional participants and score of 100% denotes maximum functional affection and decrease of the score by 10% denotes significant improvement
at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing number of lumbar facet joints showing synovitis on MRI and/or improving the grade of severity of the synovitis
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of number of lumbar facet joints showing synovitis on MRI and/or improving (decrease in) the grade of severity of the synovitis graded from 0 to 4 according to the extent of lumber facet joint synovitis on MRI documented just before the intervention and at 3 month after the intervention
at 3 month follow up post intervention for each patient
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
Czervionke LF, Fenton DS. Fat-saturated MR imaging in the detection of inflammatory facet arthropathy (facet synovitis) in the lumbar spine. Pain Med. 2008 May-Jun;9(4):400-6. doi: 10.1111/j.1526-4637.2007.00313.x.
Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
Sae-Jung S, Jirarattanaphochai K. Outcomes of lumbar facet syndrome treated with oral diclofenac or methylprednisolone facet injection: a randomized trial. Int Orthop. 2016 Jun;40(6):1091-8. doi: 10.1007/s00264-016-3154-y. Epub 2016 Mar 18.
Zhang J, Middleton KK, Fu FH, Im HJ, Wang JH. HGF mediates the anti-inflammatory effects of PRP on injured tendons. PLoS One. 2013 Jun 28;8(6):e67303. doi: 10.1371/journal.pone.0067303. Print 2013.
Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
Maas ET, Juch JN, Ostelo RW, Groeneweg JG, Kallewaard JW, Koes BW, Verhagen AP, Huygen FJ, van Tulder MW. Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints. Eur J Pain. 2017 Mar;21(3):403-414. doi: 10.1002/ejp.963. Epub 2016 Oct 10.
Manchikanti L, Datta S, Gupta S, Munglani R, Bryce DA, Ward SP, Benyamin RM, Sharma ML, Helm S 2nd, Fellows B, Hirsch JA. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. 2010 Jul-Aug;13(4):E215-64.
Kotb SY, Sherif NM, Saleh HA, Ahmed SF, Sakr HM, Taeimah MO. The role of intra-articular injection of autologous platelet-rich plasma versus corticosteroids in the treatment of synovitis in lumbar facet joint disease. Saudi Med J. 2022 Nov;43(11):1200-1208. doi: 10.15537/smj.2022.43.11.20220449.
Mohamed Taeimah, MD
Faculty of Medicine Ain Shams University
Shahdan Kotb
Faculty of Medicine Ain Shams University
Study Start
September 17, 2019
Actual (reported)Primary Completion
January 22, 2021
Actual (reported)Study Completion
January 22, 2021
Actual (reported)Last Updated
May 4, 2021
Record last verified: 2021-05
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